Axsome Therapeutics, Inc Wells Fargo 21st Annual Healthcare Conference

Thank you all. Thanks for having us.

Yes. Yeah, great to be here.

Sure, I'd be happy to. Maybe I'll start and then hand it over to Nick. Axsome, CNS-focused biopharma. We have three products that are commercial products. Those are AUVELITY for major depressive disorder and agitation associated with Alzheimer's disease. There's SYMBRAVO for migraine, and Sunosi for excessive daytime sleepiness and obstructive sleep apnea and narcolepsy. All products are growing robustly. Nick can share some of those numbers. Of course, for AUVELITY, we have recently expanded that team. We are seeing robust growth beginning in major depressive disorder, or I should say, continuing. The launch effort around the newest indication, Alzheimer's disease agitation, is underway. Both of those efforts have started to come online this summer. We can get into the details, but that's the commercial business.

The company is. The foundation and growth is better than it's ever been, and we're very excited about the opportunity moving forward for the on-market products. Behind those, we have a very late-stage and deep pipeline. We can cover those, but very quickly, that covers a number of indications and states of development. We have AXS-12 for narcolepsy. That is under NDA review with the FDA. We have a PDUFA date of May 1, and then multiple phase III trials underway in indications from binge eating disorder, ADHD, smoking cessation. A lot of additional ways to deliver value to patients, with potential label expansion efforts for the products that are on market now and new entrants. We're happy to cover those, but the pipeline is also more robust and late-stage than it's ever been.

The foundation is great, and we're really excited about where we are today, about three-quarters of the way through the year. I'll turn it to Nick in case you want to review some of the financials.

Yeah, sure. As Mark said, it's a unique and exciting time now at Axsome. It's really like the next chapter of Axsome's story, and I say that because we have the approval and the launch in ADA, and secondly, we've more than doubled the sales team for AUVELITY. Super exciting about the back half of the year. We're seeing already impacts from both the expansion, significant impacts on the expansion, which we could talk about a little bit more later on the NBRx, and also as it relates to the indication and taking a look at subpopulations and seeing that dynamic growth that we have. We're really pleased with that.

From a financial perspective, balance sheet, we are in the best situation that we have been really since inception of the company, right around $330 million as of the end of Q2, takes us to cash flow positivity, which we have shared in the past. That being said, we are also seeing in the P&L significant operating leverage in the back half of the year, where we really feel we are setting ourselves up in the first half of the year with the SG&A, with the expansion. The P&L has already been impacted on where we expect to be for the back half of the year. Really plateauing out from an OpEx and seeing a nice growth on the top line. Seeing the operating leverage and eventually getting to profitability.

The early feedback is, obviously it is very early, but we are very excited about the feedback we are getting, which is in line and matches the profile that we saw in the clinic, and then the data that are on the label. Robust efficacy. It is working quickly, and the safety and tolerability profile is very compelling, especially in this patient population that is considered a frail or at higher risk patient population. That is great. It is still very early, and we want to. The effort here and a key focus for us is driving trial and ensuring we are educating potential prescribers about the product profile and then ensuring that if they have a potentially appropriate patient that they are interested in trying the product in, that they can do so. That can vary depending on the setting, long-term care or a community setting.

We have a sampling program in place to facilitate that. The majority of patients have Medicare. So that is a different type of. There is no copay assistance program in place for those patients. There are other ways to support potential trial, primarily through sampling efforts.

Yeah. Quantitatively, what we are seeing with the launch is prior to launch, LTC Medicare 65+ was less than 20% of our total NBRx. Most recently, we are now north of 30% of our NBRx is that specific subpopulation. Really seeing the growth there, as it relates specifically for the indication.